New FDA Guidances: (1) AI in Devices, (2) How FDA Writes Guidances

 

FDA has released a  new guidance for the use of AI in medical devices, and new guidance on best-practices for guidance.

AI in Medical Devices (PCCP)

Coverage at Forbes here.   Healthcare Dive here. The FDA document itself, is specific to: "predetermined change control plans (PCCPs)" for AI in medical devices.  (The draft had been issued 4/2023).

FDA thinking on PCCP in general, may be important for genomic tests as well, which are also frequently updated.

How FDA Writes Good Guidances

FDA has also released guidance, on how it writes guidances.  See AgencyIQ at LinkedIn here.   (They provide an open access 6p white paper).  And see the FDA home page for the topic, updated December 2, 2024 - here.  See the  December 3, 2024 Fed Reg notice, 89FR95799.  

See a 27 page draft report on "best practices" for guidances here.  See the final report here.  AgencyIQ, in their 6p white paper, warns the final report may fall short of industry expectations.

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Separately, see a new Endpoints article on FDA guidance for accelerated drug withdrawals here.

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AI Corner

Chat GPT 4 summarizes in 100 words or less.

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The FDA's guidance on Predetermined Change Control Plans (PCCPs) for AI-enabled medical devices provides a framework to support iterative improvements while ensuring safety and effectiveness. PCCPs outline planned modifications, methods for validation, and risk assessments. Once a PCCP is authorized, manufacturers can implement changes without additional marketing submissions, provided they follow the approved protocol. This approach aims to streamline updates, encourage innovation, and maintain regulatory compliance. 

Key components include descriptions of modifications, modification protocols, and impact assessments. The FDA emphasizes quality system adherence, transparency in device labeling, and encourages early engagement through the Q-Submission Program to refine PCCPs.

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The FDA's "Report and Plan on Best Practices for Guidance" outlines strategies to enhance transparency, consistency, and efficiency in guidance document creation and use. Key elements include standardizing formats, improving public comment processes, and utilizing technology for better communication. The FDA aims to streamline regulatory submissions and make guidance documents accessible and responsive to evolving scientific and public health needs. Public input is prioritized for Level 1 guidance, except in urgent cases, while outreach via various platforms ensures broad accessibility. Periodic reviews will assess the relevance of guidance, maintaining alignment with current regulatory and public health priorities.

• Level 1 Guidance: Addresses new or significant interpretations of laws/regulations, policy changes, complex scientific issues, or controversial topics. It requires more rigorous internal review and public comment before finalization.
• Level 2 Guidance: Focuses on existing practices, minor policy clarifications, or technical corrections. It has simpler procedures, often skipping extensive reviews and public comment, making it faster to develop and issue.

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Agency IQ (6 page white paper)

Per AgencyIQ, the FDA's final report on guidance development outlines plans to enhance transparency, efficiency, and stakeholder engagement. Key initiatives include updating the Good Guidance Practices (GGP) regulation to align with modern technology, streamlining comment processes, and improving guidance accessibility through expanded online resources. Specific changes involve standardized formats, line-numbered drafts, and expanded guidance agendas, including for the Oncology Center of Excellence. While incorporating some stakeholder suggestions, the FDA's report largely focuses on its internal priorities, leaving many industry requests unmet. Future regulatory updates to the GGP regulation may provide additional opportunities for stakeholder input on improving the guidance

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What industry needs were unmet?

According to AgencyIQ, the FDA’s final report on guidance documents left several industry needs unmet, including:

1. Standardized Templates: Industry requested a universal template for all FDA guidance documents to improve consistency and clarity. This was rejected due to the diverse needs of different Centers.

2. Detailed Comment Summaries: Stakeholders sought comprehensive summaries of FDA’s responses to public comments on guidance documents, which were not incorporated.

3. User-Friendly Access: Suggestions to create centralized, easy-to-download folders of stakeholder comments or maintain a single webpage listing all withdrawn guidance documents were declined.

4. Flexible Formats: Requests to use non-PDF formats, such as web-based or interactive guidance documents, were ignored, maintaining the current reliance on PDF.

5. Greater Responsiveness: Stakeholders highlighted the need for the FDA to adapt lessons from the COVID-19 pandemic, such as faster guidance dissemination, for non-emergency contexts. This was not reflected in the final report.

6. Broader Use of Level 2 Guidance: While Level 2 documents are easier to develop, FDA limited their use, frustrating those seeking a more flexible and rapid guidance process.

7. Expanded Public Input: Calls for broader mechanisms to influence guidance development or suggest revisions were only partially addressed with minimal procedural updates.

These omissions reflect the FDA's focus on internal efficiency and priorities rather than fully addressing stakeholder-driven reforms